Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil - a double blind, randomized, placebo-controlled, monocentric phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003196-21-DE

Enrollment

Registered

2006-04-27

Start date

2008-01-22

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inpatients of the Psychiatric Hospital of the Technical University of Munich Diagnoses: - Depressive episode with somatic symptoms (ICD-10: F32.01, F32.11, F32.21) - Recurrent depressive disorder with somatic symptoms (F33.01, F33.11, F33.21) - Bipolar affective disorder, presently depressive episode with somatic syndrome (F31.31, F31.41) Age 18 – 70 years Hamilton Depression Score (HAMD-21) at baseline > 18

Interventions

Trade Name: Vigil Product Name: Vigil Pharmaceutical Form: Tablet INN or Proposed INN: Modafinil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inpatients of the Psychiatric Hospital of the Technical University of Munich Diagnoses: - Depressive episode with somatic symptoms (ICD-10: F32.01, F32.11, F32.21) - Recurrent depressive disorder with somatic symptoms (F33.01, F33.11, F33.21) - Bipolar affective disorder, presently depressive episode with somatic syndrome (F31.31, F31.41) Age 18 – 70 years Hamilton Depression Score (HAMD-21) at baseline > 18 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Presence of psychotic symptoms Substance dependence (history or present) Present psychiatric comorbidity Relevant medical conditions Acute suicidality History of seizures Paroxysmal EEG activity

Design outcomes

Primary

Measure	Time frame
Main Objective: It is the aim of the study to investigate whether the administration of modafinil during a 40 hour sleep deprivation period in depressed patients can intensify the antidepressant effect of the sleep deprivation. Hypothesis : There is a negative correlation between the total sleep time during the sleep deprivation period and the improvement in depression scores. ;Secondary Objective: None;Primary end point(s): Improvement of depression score under sleep deprivation therapy and treatment with modafinil as compared with placebo	—

Measure

Time frame

Main Objective: It is the aim of the study to investigate whether the administration of modafinil during a 40 hour sleep deprivation period in depressed patients can intensify the antidepressant effect of the sleep deprivation. Hypothesis : There is a negative correlation between the total sleep time during the sleep deprivation period and the improvement in depression scores. ;Secondary Objective: None;Primary end point(s): Improvement of depression score under sleep deprivation therapy and treatment with modafinil as compared with placebo

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026